1. Field of the Invention
This invention is directed to a closure assembly for use on a female luer connector or other generally similar connector of the type used with intravenous (IV) administration assemblies for the dispensing IV fluid and/or the adding of medicine or other agents to the IV container for dispensing. The closure assembly is structured to restrict unauthorized access to the female luer connector and further, to provide an obvious indication of attempted access to or other efforts to tamper with the female connector and/or contents of the IV reservoir.
2. Description of the Related Art
In the medical field, it is a relatively common procedure to administer fluids to a patient by intravenous (IV) infusion. A variety of IV assemblies are known and are useful in the treatment of a number of medical conditions, in that a variety of fluids and/or medicines can be administered to a patient utilizing such assemblies over a prescribed period of time and in controlled amounts. In use, a conventional IV administration assembly typically includes a reservoir or container, in the form of a bottle or more commonly, a flexible material bag, suspended on a pole or like support structure located substantially adjacent to the patient being treated, typically in an elevated relation thereto. In addition, the IV fluid flows from the supported and elevated IV bag to the patient by means of elongated, flexible tubing connected at a proximal end to the IV bag and at the other distal end, connected intravenously to the patient by way of a catheter or like structure. The IV delivery tube is also structured to connect at one end to or be interconnected with an appropriate connector, often having somewhat of a “Y” shape, that is associated with the IV assembly and in fluid communication with either the contents of the IV bag or alternatively, with the catheter in use on the patient for intravenous administration of fluids and medicines.
One such connector may be in the form of a female connector attached to the IV bag or other container and disposed in fluid communication with the contents thereof. An appropriate female connector may be in the form of a female luer connector which at least partially defines, along with a male luer connector, a “luer lock” connector assembly, as is well known in the medical profession. The male luer connector is secured to the IV delivery tubing, such as at the proximal end, and is specifically structured to be attached to the female luer connector in a manner which establishes fluid communication with contents of the IV container, and facilitates a flow of the IV fluid from the IV container through the connected male and female luer connectors. As a result, fluid flow between the patient and the interior of the IV bag is established. As is also well known, various types of valves and/or flow regulating devices may be operatively associated with the IV assembly to regulate the amount of fluid or rate of fluid delivery to the patient during the administration procedure.
In addition, known IV containers or reservoirs may incorporate an additional female luer connector or other female type connector which are disposed in fluid communication with the IV delivery tubing, such as but not limited to at the IV bag. This additional female luer connector is provided to administer additional liquid agents, such as pain medication, antibiotics, and/or other medicinal compositions, to the IV fluid being delivered to the patient. However, such an additional female luer connector may remain unused or may be accessed at a time subsequent to the initiation of the IV fluid administration, such as when additional medication or another composition is required or prescribed.
In periods of non-use, it is important to maintain a female luer connector in a closed and fluid sealed condition in order to maintain sterility, and also, the integrity of the IV fluid prior to use. This is also important in order to restrict unauthorized access to the IV fluid and even to the female luer connector. Therefore, there is a need in the medical field for an efficient, effective and easily applied closure assembly that would be capable of closing and sealing a female connector during periods of its non-use. If any such closure assembly were developed, it should also be structured to provide a clear visual indication whenever there has been tampering or other attempted access to the female luer connector and/or contents of the IV container. Moreover, if any such closure assembly were developed, it should also be structured for efficient attachment to the female luer connector so as to prevent re-attachment to the female connector, once unauthorized access has been attempted or accomplished. If any such closure assembly were developed, it should also be capable of being removed from the female connector in a manner which provides the aforementioned visual or other appropriate indication of complete, partial or other attempted access to the female luer connector.
Finally, the structural components as well as the operational characteristics of any such closure assembly developed should ideally also provide a sufficient degree of reliability relating to the secure closing and sealing of the female connector of the IV container, while restricting access and clearly indicating when access thereto has occurred or been attempted.